NEORAL

Generic Name/API: cyclosporine

Manufacturer: Novartis

Dosage Forms & Strength & Pack Size:
Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED
25 mg
Oval, blue-gray imprinted in red, “Neoral” over “25 mg.”
Packages of 30 unit-dose blisters (NDC 0078-0246-15).
100 mg
Oblong, blue-gray imprinted in red, “NEORAL” over “100 mg.”
Packages of 30 unit-dose blisters (NDC 0078-0248-15).
Store and Dispense
In the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).
Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED
A clear, yellow liquid supplied in 50 mL bottles containing 100 mg/mL (NDC 0078-0274-22).

Storage:
Store and Dispense
In the original container at controlled room temperature 68°F to 77°F (20° to 25°C). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F
(20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
Kidney, Liver, and Heart Transplantation
Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
Neoral has been used in combination with azathioprine and corticosteroids.
Rheumatoid Arthritis
Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
Psoriasis
Neoral is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated or cannot be tolerated.
While rebound rarely occurs, most patients will experience relapse with Neoral as with other therapies upon cessation of treatment.

CONTRAINDICATIONS
General
Neoral is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation.
Rheumatoid Arthritis
Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive Neoral.
Psoriasis
Psoriasis patients who are treated with Neoral should not receive concomitant PUVA or UVB therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. Psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive Neoral.
WARNINGS
(See also BOXED WARNING.)
All Patients
Cyclosporine, the active ingredient of Neoral, can cause nephrotoxicity and hepatotoxicity. The risk increases with increasing doses of cyclosporine. Renal dysfunction, including structural kidney damage, is
a potential consequence of Neoral and therefore renal function must be monitored during therapy. Care should be taken in using cyclosporine with nephrotoxic drugs (see PRECAUTIONS).
Patients receiving Neoral require frequent monitoring of serum creatinine (see Special Monitoring under DOSAGE AND ADMINISTRATION). Elderly patients should be monitored with particular care, since decreases in renal function also occur with age. If patients are not properly monitored and doses are not properly adjusted, cyclosporine therapy can be associated with the occurrence of structural kidney damage and persistent renal dysfunction.
An increase in serum creatinine and BUN may occur during Neoral therapy and reflect a reduction in the glomerular filtration rate. Impaired renal function at any time requires close monitoring, and frequent
dosage adjustment may be indicated. The frequency and severity of serum creatinine elevations increase with dose and duration of cyclosporine therapy. These elevations are likely to become more pronounced without dose reduction or discontinuation.
Because Neoral is not bioequivalent to Sandimmune, conversion from Neoral to Sandimmune using a 1:1 ratio (mg/kg/day) may result in lower cyclosporine blood concentrations. Conversion from
Neoral to Sandimmune should be made with increased monitoring to avoid the potential of underdosing.
Kidney, Liver, and Heart Transplant
Nephrotoxicity
Cyclosporine, the active ingredient of Neoral, can cause nephrotoxicity and hepatotoxicity when used in high doses. It is not unusual for serum creatinine and BUN levels to be elevated during cyclosporine therapy. These elevations in renal transplant patients do not necessarily indicate rejection, and each patient must be fully evaluated before dosage adjustment is initiated.
Based on the historical Sandimmune experience with oral solution, nephrotoxicity associated with cyclosporine had been noted in 25% of cases of renal transplantation, 38% of cases of cardiac
transplantation, and 37% of cases of liver transplantation. Mild nephrotoxicity was generally noted 2 to 3 months after renal transplant and consisted of an arrest in the fall of the pre-operative elevations of BUN
and creatinine at a range of 35 to 45 mg/dL and 2.0 to 2.5 mg/dL, respectively. These elevations were often responsive to cyclosporine dosage reduction.
More overt nephrotoxicity was seen early after transplantation and was characterized by a rapidly rising BUN and creatinine. Since these events are similar to renal rejection episodes, care must be taken to differentiate between them. This form of nephrotoxicity is usually responsive to cyclosporine dosage reduction.
Although specific diagnostic criteria which reliably differentiate renal graft rejection from drug toxicity have not been found, a number of parameters have been significantly associated with one or the other. It should be noted however, that up to 20% of patients may have simultaneous nephrotoxicity and rejection.

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